In connection with surgery for a number of diseases in the gastro-intestinal tract, one of the consequences in many cases is that the patient is left with an abdominal stoma, or ostomy, such as a colostomy, an ileostomy or a urostomy in the abdominal wall for the discharge of visceral contents. The discharge of visceral contents cannot be regulated at will. For that purpose, the user will have to rely on an appliance to collect the material emerging from such opening in a bag, which is later emptied and/or discarded at a suitable time.
An ostomy appliance may be in the form of a one-piece appliance for which a collecting bag for human body wastes is permanently, or fixedly, secured to an adhesive base plate for attachment to the human skin. Alternatively, the ostomy appliance may be a two-piece appliance comprising a base plate and a collecting bag which may be coupled to and un-coupled from each other through a coupling means. This has the effect that the base plate does not need to be separated from the skin of the user as often as exchange of the collecting bag requires. The base plate may need only to be changed every 2-4 days depending on the user, whereas the collecting bag may be changed more than once per day. Typically, it is desirable to need as few exchanges of the base plate as possible in order to reduce the risk of skin complications.
A collecting bag for human body wastes usually comprises a front wall on the distal side and a rear wall on the proximal side. The walls are made of gas- and liquid impermeable foil-material (for example of polyethylene (PE), polyvinyl-chloride (PVC) or ethylene-vinyl-acetate (EVA)) that is welded around the edges or the rim so as to form a pouch defining a waste collection chamber. The bag may be welded only partly around the rim so that an opening for emptying the bag is provided at the bottom of the bag. In that case, the bag may be provided with means for closing that opening. The waste inlet opening is provided in the rear wall and placed in the upper part of the collecting bag so that when a user stands up, the waste inlet opening will be above the midline of the collecting bag. This leaves a larger collecting volume below the waste inlet opening. Thus, the top of the collecting bag is defined as the part closest to the waste inlet opening, and the bottom is defined as the opposite part.
One of the main concerns of ostomates using ostomy appliances having an adhesive base plate for attachment to the skin surrounding a stoma, and where a collecting bag is attached to the base plate for collecting stomal output, is that the ostomy adhesive attachment may be compromised resulting in sudden leakage or even complete detachment of the ostomy appliance which can be a stigmatising experience for the user.
Numerous attempts have been made to solve this problem and even though some attempts have been partly successful, still there exist no products which completely solve this problem. Two examples are given below.
GB2311467 describes an ostomy appliance comprising a pouch and an adhesive flange coupled to the pouch for securing the appliance with respect to the skin of a wearer. The adhesive flange has an aperture which communicates with an interior of the pouch and comprises a plurality of fingers which extend away from the aperture. The document also describes an adhesive flange for an ostomy appliance.
WO2012/052032 discloses an ostomy bag having an outer rotatable adhesive fitting wafer attached thereto. The solution offers a higher degree of customization to the user, as the user may cut the adhesive fitting wafer in such a way that it fits to the contour of the skin and the user may also rotate the ostomy bag relative to the wafer in order to achieve a desired orientation of the ostomy bag.
One reason why this problem is so difficult to solve is the fact that stomas and peoples anatomy are by definition highly individual. Different considerations need to be made for thin people than for larger people, for different skin types, for the position of the stoma which may vary a lot from person to person, for scar tissue surrounding the stoma, local irregular skin topography, e.g. hernias and wounds, and more—and in particular where combinations of some, or all of the above exist.
Thus, there is a need to further develop and find improvements in order to solve this problem. In other words, there exists a need to further customize or personalize ostomy appliances to fit the individual user's anatomy to increase the securement of the appliance to the skin surface.
The present invention provides the user with the possibility of improving the security of the attachment of the ostomy appliance to the skin and thus reduces the risk of sudden leakage and detachment of the appliance by facilitating an improved and differentiated, individually adapted attachment of the appliance.